HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The use of corticosteroids in patients with severe community pneumonia, bacterial infection which kills lots of patients around the world, reduces the mortality of this infection. However, there are no studies with this type of drug regarding hospital-acquired pneumonia. This will be the first multicenter randomized, double-blind, controlled trial to test hydrocortisone plus standard therapy in critical care patients with nosocomial pneumonia. This intervention is inexpensive and may improve the outcome of those patients, besides having an acceptable side effects profile.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
• Collaborators: Fundação Faculdade Regional de Medicina de São José do Rio Preto; Hospital de Câncer de Barretos; Hospital Samaritano Paulista; Instituto do Cancer do Estado de São Paulo; University of Sao Paulo
• Treatments: Hydrocortisone; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

• 18 years of age or older

• Suspected ou confirmed case of bacterial nosocomial pneumonia (including ventilator-associated pneumonia)

• Intensive Care Unit stay

• Signed consent form (by the patient or a legal guardian)

Exclusion Criteria:

• Women who are pregnant, have recently given birth or are breastfeeding

• Patients who are moribund or do not have a treatment perspective

• Patients with community acquired pneumonia

• Patients with other types of pneumonia (viral - including COVID-19, fungal etc.)

• Those with pulmonary infiltrates in chest image which are not compatible with bacterial pneumonia

• Patients with adrenal insufficiency

• Patients who have a condition that demands the use of corticosteroids (acute or chronic)

• Patients allergic to hydrocortisone

• Patients with refractory septic shock (those receiving more than 0,5mcg/kg/min of norepinephrine)